Hasil untuk "Medical legislation"

David C. Klonoff, Agatha F. Scheideman, Mandy M. Shao et al.

Abstract Current regulatory frameworks in the United States (US) and the European Union (EU) provide medical data privacy protections, but do not explicitly establish ownership rights. Legislation increasingly recognizes the rights of persons with chronic diseases for data ownership, but clinicians, researchers, public health professionals, and medical device manufacturers can also stake claims to ownership. Effective translational medical research requires policies for using patient-generated data to help society while still protecting the rights of patients from whom the data was obtained. Four increasingly important areas related to the ownership of patient-generated research data are discussed in this article, including (1) US and European laws relating to medical data ownership, (2) stakeholders claiming ownership of medical data, (3) the need for ownership laws to support translational medicine research, and (4) emerging controversies in medical data ownership. Translational research requires secure and legal acquisition of data streams. Technological and policy strategies for data ownership are increasingly needed that respect the rights of all involved stakeholders. No specific legislation in the US and various EU Member States explicitly recognizes ownership rights of medical data. Recent regulatory initiatives like the Trusted Exchange Framework and Common Agreement (TEFCA) in the US and the European Health Data Space Regulation (EHDS) in European Union Member States have strengthened patients’ access to and control of their medical data, but they do not establish medical data ownership rights. The absence of clear ownership rules continues to raise ethical, technical, and legal challenges as medical data sharing expands across international borders.

Sohee Bae, Seungsoo Lee, Junwoo Lee et al.

Objectives As the importance of ESG in industry increases, global pharmaceutical & biotechnology companies are actively adopting circular economy principles in alignment with ESG reporting standards. With stricter environmental regulations emerging in Europe and the U.S., it is necessary for Korean companies focusing on the CDMO (Contract Development and Manufacturing Organization) to adapt to the changes. This research aims to provide suggestions for Korean companies to secure global competitiveness by improving their waste management strategy based on the circular economy through the case of global companies. Methods The waste management and circular economy strategies of the global top 10 companies, waste management leaders, and Korean pharmaceutical and biotech companies (Yuhan, Hanmi Pharm, Celltrion, SK Bioscience) were analyzed in three stages: plastic waste reduction, value chain management, and take-back policies. Results and Discussion Global companies were disclosing quantitative achievements in their plastic reduction strategies, introducing solutions in the transportation process that included supply chains, and establishing extended producer responsibility legislation (EPR) policies for pharmaceuticals and medical devices. In contrast, Korean companies lack detailed goals and measurable outcomes in these areas, with limited participation in global initiatives and insufficient EPR strategies due to a lack of government regulation. Conclusion Korean pharmaceutical & biotech companies should establish strategies, such as upgrading plastic waste management systems, converting packaging materials, joining initiatives, and introducing take-back programs, with transparently disclosing their performance to achieve circular economic goals and strengthen their competitiveness in the global market.

Muhammad Asif Shahzad, Momin Ayub Marath

Background: Over the years, the epidemiology of maxillofacial fractures keeps changing and new trends in etiology, pattern of presentation and management are constantly evolving. This, therefore, necessitates a constant appraisal of these fractures injuries in order to keep abreast with recent developments and changing pattern of their management. The aim of this study was to determine the frequency, etiology, patterns and different treatment modalities for maxillofacial fractures in patients treated at Lahore Medical and Dental College/Ghurki Trust Teaching Hospital (LMDC/GTTH). Methods: This cross sectional descriptive study was carried out at Lahore Medical and Dental College/Ghurki Trust Teaching Hospital (LMDC/GTTH) from February 2014 to October 2017.A total of 161 patients having maxillofacial fractures were included in the current study. Data on patients, including age, gender, cause of injury, fracture site, pattern and treatment modalities were collected and analyzed using SPSS version 20. Results: The age range was 3 to 62 (mean/SD, 26.42±11.24) with peak frequency occurring in age group 21-30 years. The male to female ratio was 5.2:1. The most common cause of maxillofacial fractures was road traffic accident (RTA) in 134 (83.23%) of patients, followed by in fall 12 (07.46%) and assault in 09 (05.59%) patients. The most frequent bone fractured was the mandible, which accounted for 117 (72.67%) cases and parasymphysis (43.22%) was the most frequent site affected, followed by 67 (41.61%) cases of zygomatic complex fracture and 56 (34.78%) cases of maxillary fractures. Open reduction and internal fixation (ORIF/ORIF with IMF) was performed in 127(78.88%) of patients while closed reduction and indirect fixation (IMF with eyelet wiring/arch bar elastics & splint fixation) was done in 34 (21.12%) of patients. Conclusion: As evidenced by the present study, majority of fractures were caused by RTA in 21-30 age group with male predominance. Mandible was the predominant fractured bone followed by the zygomatic complex area. ORIF was treatment of choice in the current study. According to present study, it seems reasonable to recommend that road traffic legislation enforcement and continuous public education towards the use of restraining devices and helmets should be encouraged by relevant authorities.

D. S. Yurochkin, D. D. Mamedov, S. E. Erdni-Garyaev et al.

In the formation of a common market within the framework of interstate associations (Unions), the goal of improving the health of the member states population can be achieved, among other things, by providing an unimpeded access to safe, effective and quality medicines (drugs). One of the elements is activities in the field of these medicinal products  compounding. This review has been prepared by authors due to the lack of information in the Russian-language literature  on the regulation of this area in the current legal systems of the BRICS countries.The aim of the work was to analyze the regulatory mechanisms and current approaches to the organization of activities in the field of medicinal products compounding, presented in the legislation of the BRICS interstate association (Union) member countries, including their structuring (systematization) in order to develop proposals for the convergence of these practices.Materials and мethods. PubMed, Google Scholar, elibrary.ru, and specialized databases of regulatory legal documents of the BRICS countries were used as search resources. The following keywords were used as search keywords: “drug”, “drug product”, “medicinal products compounding”, “pharmacy organization”, “medical organization”, “compounding”, “drug preparation”, “drug dilution (reconstitution)” in English, Portuguese, Spanish, Chinese and Arabic. The paper uses empirical, theoretical, quantitative tools, including the analysis of a wide list of relevant sources - regulatory legal documents governing the activities of compounding pharmacies in the BRICS countries.Results. The study presents key regulatory legal acts and documents, analyzes them and describes the main provisions of the legislative framework for the organization of activities in the field of medicinal products compounding. The identified peculiarities determine the need to rethink the current state of the Russian regulation of the medicinal products compounding sector. The study emphasizes the need to improve regulatory approaches in Russia. The BRICS countries can strive to develop the best practices and “gold” standards for the organization of this socially important activity in the field of medicinal products compounding. Such an approach can led to the creation of a unified good practice in compounding and dispensing of medicinal products. Conclusion. The authors of the study consider it advisable to carry out a further and more detailed elaboration of the convergence issues of regulatory practices of both health care systems and pharmaceutical industries in the BRICS member states. It has been proposed to develop and form a “Roadmap” (an action plan) for the development of the cooperation between the BRICS member states in the field of health care and pharmaceutical industry in order to intensify integration processes and build a modern model of the public health and drug market, including joint research and development by world-class scientific centers for technological development of the interstate association (Union) countries.

Joaquin Lucena

RESUMEN El papel de la medicina forense en la investigación de la muerte súbita es crucial, ya que desde el punto de vista jurídico, como en su forma de presentación, así como el desconocimiento de la existencia de una patología natural o, en su caso, la falta de testigos, hacen que se trate de una muerte “sospechosa”. De ahí que sea el patólogo forense el responsable de determinar su causa precisa. La autopsia puede representar en estos casos la primera y última oportunidad para hacer el diagnóstico correcto de la causa de la muerte, lo cual es de suma relevancia, especialmente para los familiares. A pesar de la relevancia de su estudio, aun se necesita realizar mas investigación, para su mejor comprensión; especialmente la relacionado a la Muerte Súbita no cardiovascular. ABSTRACT The role of forensic medicine in the investigation of sudden death is crucial, since from the legal point of view, as well as in its form of presentation, as well as the lack of knowledge of a previous natural pathology or, where appropriate, the lack of witnesses, make it a “suspicious” death. Hence, the forensic pathologist is responsible for determining its precise cause. The autopsy can represent in these cases the first and last opportunity to make the correct diagnosis of the cause of death, which is of utmost relevance, especially for relatives. Despite its relevance, more research still needs to be done, especially related to non-cardiovascular sudden death.

Maria do Carmo de Carvalho e Martins, Lucíola Galvão Gondim Corrêa Feitosa, Gillian Santana de Carvalho Mendes et al.

Este estudo teve como objetivo descrever aspectos éticos e a aplicação das diretivas antecipadas de vontade ao direito brasileiro. Tratou-se de revisão integrativa baseada em 23 de 47 artigos elegíveis, selecionados após leitura e análise de trabalhos localizados nas bases de dados Scopus, ScienceDirect, SciELO, Lilacs e Google Acadêmico. A busca foi realizada utilizando combinação dos descritores “diretivas antecipadas”, “doente terminal”, “testamento vital”, “ética”, “aspectos éticos”, “aspectos legais” e “direito brasileiro”, além dos termos correspondentes em inglês. Embora tenham por finalidade assegurar o respeito à autonomia e à autodeterminação do paciente, as diretivas antecipadas de vontade causam controvérsias em razão de implicações éticas, jurídicas e religiosas. Há dilemas morais e jurídicos relacionados com a possibilidade de o doente dispor de seu corpo e de sua vida, ainda que em situação de intenso sofrimento e perda de bem-estar e qualidade de vida pela terminalidade de vida. A admissibilidade desse instituto jurídico no cenário brasileiro é necessária tanto pelo imperativo de adequação e harmonia internacional quanto pelo estado da arte da ciência médica e de aspectos da morte digna como novo parâmetro ético.

Sara Manellari, Maria Grazia Leone, Antonella Casiraghi et al.

European legislation provides that each product used for healthcare purposes be regulated according to specific directives and regulations based on its intended use and mechanism of action. However, qualification issues may arise for medical devices, their accessories, and medicinal products. This is the case with gases for spirometry, which support spirometers in measuring patients’ pulmonary capacities. This article discusses criticisms connected to their proper regulatory qualification, detailing why they should be more properly qualified as accessories of medical devices instead of as medicinal products or medical devices.

Metin Cevizci

While educational legislation specifies that doctors and psychologists are responsible for making the diagnosis of learning difficulties and that it is up to the school actors to adapt their teaching methods, a field survey of several schools in Istanbul reveals a very different reality. Explaining school difficulties by neurodevelopmental disorders is linked to the economic, social and institutional conditions in which pupils find themselves and is based on a negotiated order (Strauss, 1992) between school and medical-psychological actors. School failure thus now draws upon a complex professional market, whose interface with schools remains haphazard and further deepens socio-educational inequalities.

Natasha Harris

Since the legalization of Medical Assistance in Dying (MAID) in Canada in 2016, there have been discussions regarding the extension of this service to patients who lose decision-making capacity but have made a prior advance request for physician-assisted suicide. Both caregivers and physicians have shown some support for allowing patients to make advance requests for MAID. The proposed changes to the legislation would remove the mandatory 10 day waiting period and include a waiver of final consent for those who loose decision-making capacity following their MAID request.

V. M. Isaev, E. N. Pashkova

The article discusses some of the problematic issues of the law enforcement of a medical examination for drug intoxication as a measure of ensuring the proceedings in an administrative case, and the use of the results of this examination as evidence in a case of an administrative offense. Certain contradictions of the legislation governing the medical examination procedure and the procedural features of the use of the results obtained in deciding on an administrative offense case have been identified. The necessity of introducing amendments to the legislation aimed at increasing the level of legal protection of citizens, including those brought to administrative responsibility, is substantiated. Separate directions are proposed for improving the legal and organizational framework for conducting the examination for drug intoxication, including the establishment of common criteria for assessing the state of intoxication, taking into account acceptable levels of threshold levels of narcotic drugs, psychotropic substances, other chemicals and their metabolites in the human body.

S. C. Bodley

The College of Physicians and Surgeons of Ontario (CPSO) was at the forefront of policy development as the legislation on medical assistance in dying (MAiD) was coming into force. We provided much-needed guidance to the profession on this important issue after consulting broadly with the public and

Luciana Souza d’Ávila, Graciane Rafisa Saliba

Pensar a saúde como direito de todos é uma tarefa complexa, dadas as desigualdades de acesso a condições dignas de vida. Nesse sentido, o objetivo deste trabalho é discutir a efetivação do direito à saúde tendo em vista sua centralidade na busca pela justiça social. Trata-se de uma reflexão subsidiada por uma extensa análise da literatura, a qual envolveu referências relacionadas ao direito à saúde e a diversos campos da doutrina jurídica (direitos humanos, direitos sociais, Direito Constitucional e Direito Econômico), tendo em vista sua relevância para o tema estudado. Verificou-se que, apesar dos avanços na efetivação dos direitos sociais no país, há ainda muito a se fazer – principalmente quando se pensa que, em tempos de crise econômica, os cortes orçamentários recaem diretamente sobre as políticas sociais, penalizando os cidadãos mais vulneráveis e em circunstâncias adversas. O direito à saúde está inteiramente interligado ao desenvolvimento das capacidades humanas e à qualidade de vida das pessoas e coletividades, sendo que o problema do descumprimento desse direito ultrapassa a implementação do Sistema Único de Saúde. Dessa forma, a efetivação do direito à saúde é um instrumento de justiça social, pois, além de possibilitar o exercício de outros direitos, exige o repensar de estruturas e comportamentos enraizados, levando ao estabelecimento de novas relações entre as instâncias de poder e promovendo a inclusão social.

Vladimir Nikolaevich Skvortsov, Viktoriya Vladimirovna Nevzorova, Tat›yana Skvortsova et al.

At the end of the 19th century rabies was widespread in the Belgorod region. The reason for the spread were stray dogs and wolves. For the first time, rabies in animals in the veterinary reporting was point in the 1980s. As a rule, only losses of farm animals were recorded. In reports there are no cases of rabies in dogs and cats, therefore the true size of the spread of rabies is unknown. Such statistics were observed in all reports of Zemstvo›s veterinarians (Zemstvo is the elective district council in prerevolutionary Russia). In all cases, when people were bitten by rabid dogs, they were sent to Moscow and Kharkov for treatment at the expense of the Zemstvo. In the XIX century in the villages, this disease was widespread, and the population often resorted to the help of «folk healers». At the end of the XIX century in Russia there was no special legislation on infectious diseases of domestic animals, except for rinderpest. Zemsky regulations on the prevention and cessation of infectious diseases determined the statute of the medical police. The first rules on measures to prevent and stop rabies in the province were worked out by the first congress of veterinarians of the Kursk province in 1894. According to these rules, animals, sick with rabies, were immediately killed. Was years when the rabies was developed into epizootics. All this spoke about the need to take urgent measures to combat this disease.

José Julián Espinal Bueso

La práctica de la medicina de trasplante ha sido adoptada, como primera opción terapéutica, para un número creciente de enfermedades orgánicas durante los últimos 50 años. El desarrollo paralelo de formas avanzadas de cuidado en el paciente críticamente enfermo y la necesidad de órganos para trasplante, obligaron a una rápida reconsideración acerca de los criterios para definir la muerte. Diversos cuestionamientos de orden ético se plantean en relación con la asignación de órganos cadavéricos para trasplante, estos puntos de debate adquieren excepcional relevancia en un escenario de enorme demanda de órganos. Se informa sobre la importancia de la actuación del médico forense en la donación y trasplante de órganos. Se proporciona una comparación entre la anterior y la actual legislación hondureña y se indican los avances y limitantes que en relación a los trasplante de órganos presenta Honduras.

R. Gursahani, R. Mani

Anton Koychev, Tsvetelina Мihailova, Svetoslav Garov et al.

The adoption of the Health Insurance Act and the Health Act has resulted in setting up a contract based health insurance system in payment and delivery of medical services in Bulgaria. The health care reform has had a positive effect on outpatient care facilities such as the Diagnostic and Consultation Centers (DCC). The goal of the research is to analyze the activities performed in DCC XXIV-Sofia EOOD, focusing on the human, material and financial resources. Performance indicators, profitability and financial independence ratios have been calculated in order to prepare a financial and economic analysis of the activities. A thorough analysis of each resource flow would enable the management of DCC XXIV-Sofia EOOD to find ways of attracting funds through cash flow efficient management and entering into appropriate contracts in compliance with Bulgarian legislation.

Louise Rose, Craig Dale, Orla M. Smith et al.

Abstract Background Critically ill patients frequently experience severe agitation placing them at risk of harm. Physical restraint is common in intensive care units (ICUs) for clinician concerns about safety. However, physical restraint may not prevent medical device removal and has been associated with negative physical and psychological consequences. While professional society guidelines, legislation, and accreditation standards recommend physical restraint minimization, guidelines for critically ill patients are over a decade old, with recommendations that are non-specific. Our systematic review will synthesize evidence on physical restraint in critically ill adults with the primary objective of identifying effective minimization strategies. Methods Two authors will independently search from inception to July 2016 the following: Ovid MEDLINE, CINAHL, Embase, Web of Science, Cochrane Library, PROSPERO, Joanna Briggs Institute, grey literature, professional society websites, and the International Clinical Trials Registry Platform. We will include quantitative and qualitative study designs, clinical practice guidelines, policy documents, and professional society recommendations relevant to physical restraint of critically ill adults. Authors will independently perform data extraction in duplicate and complete risk of bias and quality assessment using recommended tools. We will assess evidence quality for quantitative studies using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and for qualitative studies using the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) guidelines. Outcomes of interest include (1) efficacy/effectiveness of physical restraint minimization strategies; (2) adverse events (unintentional device removal, psychological impact, physical injury) and associated benefits including harm prevention; (3) ICU outcomes (ventilation duration, length of stay, and mortality); (4) prevalence, incidence, patterns of use including patient and treatment characteristics and chemical restraint; (5) barriers and facilitators to minimization; (6) patient, family, and healthcare professional perspectives; (7) professional society-endorsed recommendations; and (8) evidence gaps and research priorities. Discussion We will use our systematic review findings to produce updated guidelines on physical restraint use for critically ill adults and to develop a professional society-endorsed position statement. This will foster patient and clinician safety by providing clinicians, administrators, and policy makers with a tool to promote minimal and safe use of physical restraint for critically ill adults. Systematic review registration PROSPERO CRD42015027860

J. LaTourelle

Maya Lyapina, Mariela Yaneva-Deliverska, Jordan Deliversky et al.

Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD), or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

Mioara ANTON

At the middle of the 1960s, communist Romania changed its demographic policy through special legislation which limited the numbers of abortions and divorces. Explained as consequence of economic and demographic conditions at that time, this legislation meant brutal intrusion by the communist power into the private life of its citizens. Romanian society had different reactions to this new regulations. According to official propaganda, many people agreed with the politics of the party concerning the birth rate and expressed their support by inviting Nicolae Ceausescu to attend weddings and baptism festivities. Behind the propaganda, the economic and social realities were different, many families being forced to live in difficult conditions. The main problems claimed by those who criticized the anti-abortion legislation were the deficiency of living spaces, the shortage of food, the high prices for goods and precarious medical aid. In time, the effects of anti-abortion legislation were disastrous for Romanian society and the propaganda apparatus was not interested in proving popular enthusiasm through letters of invitation, which explains their disappearance from the archives by the middle of the 1970s.